A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC (NiBladder 2)

A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)

Study Overview

• Status: Not yet recruiting
• Conditions: Papillary-Only Non-muscle-invasive Bladder Cancer
• Intervention / Treatment: Drug: SHR-1501+BCG; Drug: Placebo +BCG

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wenliang Wang; Phone Number: 0518-82342973; Email: wenliang.wang@hengrui.com
• Study Contact Backup: Name: Qi Zhang; Phone Number: 021-60453139; Email: qi.zhang@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100036
      • The First Medical Center of the Chinese People's Liberation Army General Hospital
      • Principal Investigator: Xu Zhang
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
      • Principal Investigator: Kai Yao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged at least 18 years, gender is not limited;
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
3. Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
4. No previous BCG therapy;
5. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
6. Sufficient hematology and organ function;

Exclusion Criteria:

1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
3. Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
4. Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
5. Those who plan to undergo radical (partial) cystectomy during the study;
6. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
7. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1501+BCG	Drug: SHR-1501+BCG; SHR-1501+BCG
Placebo Comparator: Placebo +BCG	Drug: Placebo +BCG; Placebo +BCG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AEs) as assessed by CTCAE v6.0.	Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.	Up to approximately 5 years.
Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator.	Up to approximately 5 years
Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause.	Up to approximately 5 years.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1501-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No